Paula Walser Swissmedic

- Diploma in Chemistry and PhD in Bioorganic Chemistry at the University of Basel, Switzerland (PhD completion in Dec. 1993) - 1994 - 1996: Posdoc in the pharmaceutical industry, a) one year research project on selective enzymatic reactions with microorganisms (biocatalysts with amine acylase activity); b) one year working on Isolation, purification and structure elucidation of secondary metabolites with biological activity isolated from microbial cell culture broths - 1996 - 2000: Positions in industry within the Quality Control Dept.(Basel) - Jan. 2001 - Feb. 2007: QA Manager in 2 different pharm. Industries, Synthetic APIs and Intermediates (Basel) - March 2007 - Nov. 2018: Several positions within the Quality Unit of theBiotech DS manufacturing dept. at F. Hoffmann-La Roche, Basel (incl. Head of Quality Systems, Quality Project Lead for Facility Start-up and Process Transfer Project, Deputy of Responsible Person (QP) - Dec. 2018 - Jan. 2022: Head QA and Responsible Person (QP) Biologics Manufacturing, Lonza Visp, Switzerzland (mammalian and microbial cell culture, mRNA) - Feb. 2022 - Jan. 2023: Head of Quality Systems and Compliance, Biogen International, Luterbach, Switerzerland - Since Feb. 2023: GMP/GDP inspector and license reviewer, dept. Inspectorates and Authorizations, Swissmedic Bern, Switzerland - Since Jan. 2024: Head of GMDP Inspections Operations, dept. Inspectorates and Authorizations, Swissmedic Bern, Switzerland